Actively Recruiting
Niraparib vs Niraparib Plus Bevacizumab in Patients With Platinum/Taxane-based Chemotherapy in Advanced Ovarian Cancer
Led by AGO Study Group · Updated on 2025-09-10
970
Participants Needed
65
Research Sites
480 weeks
Total Duration
On this page
Sponsors
A
AGO Study Group
Lead Sponsor
E
European Network of Gynaecological Oncological Trial Groups (ENGOT)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is an international, multicenter, randomized, open, Phase III trial to evaluate the efficacy and safety of carboplatin/paclitaxel/bevacizumab followed by bevacizumab and niraparib compared to carboplatin/paclitaxel followed by niraparib in patients with newly diagnosed advanced ovarian cancer.
CONDITIONS
Official Title
Niraparib vs Niraparib Plus Bevacizumab in Patients With Platinum/Taxane-based Chemotherapy in Advanced Ovarian Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients aged 18 years or older
- Histologically confirmed advanced high grade non-mucinous, non-clear cell epithelial ovarian cancer, peritoneal cancer, or fallopian tube cancer FIGO stage III/IV (except IIIA2 without nodal involvement)
- Upfront primary debulking surgery completed or plan to undergo chemotherapy with interval debulking surgery
- Availability of tumor samples for BRCA testing before randomization
- Ability to start systemic therapy within 8 weeks after cytoreductive surgery
- ECOG performance status of 0 or 1
- Estimated life expectancy longer than 3 months
- Adequate bone marrow function (ANC ≥ 1.5 x 10^9/L, platelets ≥ 100 x 10^9/L, hemoglobin ≥ 9 g/dL)
- Adequate coagulation parameters with stable or therapeutic INR/aPTT levels
- Adequate liver and kidney function within defined lab limits
- Normal or controlled blood pressure (≤140/90 mmHg)
- Negative pregnancy test for women of childbearing potential within 7 days prior to treatment
- Agreement to use effective contraception or abstinence during and for 6 months after treatment
- Willingness and ability to comply with study visits, treatment, tests, and questionnaires
You will not qualify if you...
- Non-epithelial ovarian tumors
- Low malignant potential or low grade ovarian tumors
- Planned intraperitoneal chemotherapy
- Other malignancies within 5 years except low-risk cancers with curative treatment
- Prior systemic treatment for ovarian cancer
- Previous PARP inhibitor treatment
- Concurrent chemotherapy, anticancer therapy, or radiotherapy during study treatment
- Prior participation or randomization in this trial
- Major surgery within 1 week before treatment or incomplete recovery from surgery
- Brain metastases or spinal cord compression
- Significant recent traumatic injury
- Recent cerebrovascular events (CVA, TIA, SAH) within 6 months
- Recent thrombotic or hemorrhagic disorders within 3 months
- Untreated or uncontrolled CNS diseases
- Pregnant or breastfeeding women
- Participation in another investigational drug trial recently
- Known allergies to study drugs or their components
- Non-healing wounds, active ulcers, or bone fractures
- Significant cardiovascular diseases including recent heart attack or heart failure
- Pre-existing neuropathy Grade 2 or higher
- History of nephrotic syndrome
- Persistent bowel obstruction
- Recent serious gastrointestinal complications
- Inability to swallow oral medication or gastrointestinal conditions affecting absorption
- Other serious diseases or conditions posing high risk during treatment
- History or current myelodysplastic syndrome or acute myeloid leukemia
- Previous bone marrow or solid organ transplant
- Recent use of high-dose aspirin or platelet aggregation inhibitors
- Poor medical risk due to serious uncontrolled diseases or infections
- Known active hepatitis B or C
- History of Posterior Reversible Encephalopathy Syndrome (PRES)
- Chronic inflammatory bowel disease under active treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 65 locations
1
Klinikum St. Marien Amberg
Amberg, Germany
Actively Recruiting
2
Klinikum Augsburg
Augsburg, Germany
Actively Recruiting
3
Hochtaunus-Kliniken
Bad Homburg, Germany
Actively Recruiting
4
Helios Klinikum Berlin-Buch
Berlin, Germany
Actively Recruiting
5
Onkologische Schwerpunktpraxis Bielefeld
Bielefeld, Germany
Actively Recruiting
6
Städt. Klinikum Brandenburg
Brandenburg an der Havel, Germany
Actively Recruiting
7
Klinikum Bremen Mitte
Bremen, Germany
Actively Recruiting
8
Klinikum Chemnitz
Chemnitz, Germany
Actively Recruiting
9
St. Elisabeth-Krankenhaus Köln-Hohenlind
Cologne, Germany
Actively Recruiting
10
Klinikum Dortmund
Dortmund, Germany
Actively Recruiting
11
Universitätsklinikum Carl Gustav Carus Dresden
Dresden, Germany
Actively Recruiting
12
Florence-Nightingale-Krankenhaus Düsseldorf
Düsseldorf, Germany
Not Yet Recruiting
13
Universitätsfrauenklinik Düsseldorf
Düsseldorf, Germany
Actively Recruiting
14
KEM Essen | Evang. Kliniken Essen-Mitte gGmbH
Essen, Germany
Actively Recruiting
15
Universitätsklinikum Essen
Essen, Germany
Actively Recruiting
16
Klinikum Esslingen GmbH
Esslingen am Neckar, Germany
Actively Recruiting
17
Universitätsklinikum Frankfurt
Frankfurt, Germany
Actively Recruiting
18
Klinikum Frankfurt Höchst
Frankfurt am Main, Germany
Actively Recruiting
19
Universitätsklinikum Gießen
Giessen, Germany
Actively Recruiting
20
Klinikum Gütersloh
Gütersloh, Germany
Actively Recruiting
21
Universitätsklinikum Halle
Halle, Germany
Actively Recruiting
22
Albertinen Krankenhaus
Hamburg, Germany
Actively Recruiting
23
Mammazentrum HH am Krankenhaus Jerusalem
Hamburg, Germany
Actively Recruiting
24
Universitätsklinikum Hamburg-Eppendorf
Hamburg, Germany
Actively Recruiting
25
Gynäkologisch-Onkologische Praxis am Pelikanplatz
Hanover, Germany
Actively Recruiting
26
Universitätsklnikum Heidelberg
Heidelberg, Germany
Actively Recruiting
27
Klinikum am Gesundbrunnen / SLK-Kliniken Heilbronn GmbH
Heilbronn, Germany
Actively Recruiting
28
Gyn.-onkolog. Gemeinschaftspraxis Hildesheim
Hildesheim, Germany
Actively Recruiting
29
Universtitätsklinikum Jena
Jena, Germany
Actively Recruiting
30
Städtisches Klinikum Karlsruhe
Karlsruhe, Germany
Actively Recruiting
31
ViDia Christliche Kliniken Karlsruhe
Karlsruhe, Germany
Actively Recruiting
32
Klinikum Kassel
Kassel, Germany
Actively Recruiting
33
Klinikverbund Kempten-Oberallgäu gGmbH
Kempten, Germany
Not Yet Recruiting
34
Klinikum Konstanz
Konstanz, Germany
Not Yet Recruiting
35
Zentrum für ambulante gynäkologische Onkologie am HELIOS Klinikum Krefeld
Krefeld, Germany
Actively Recruiting
36
Universitätsklinikum Leipzig
Leipzig, Germany
Actively Recruiting
37
St. Vincenz Krankenhaus
Limburg, Germany
Actively Recruiting
38
Klinikum Ludwigsburg
Ludwigsburg, Germany
Actively Recruiting
39
UKSH Campus Lübeck
Lübeck, Germany
Actively Recruiting
40
Universitätsmedizin Mainz
Mainz, Germany
Actively Recruiting
41
Universitätsklinikum Mannheim GmbH
Mannheim, Germany
Actively Recruiting
42
UKGM Gießen/Marburg Standort Marburg
Marburg, Germany
Actively Recruiting
43
Mühlenkreiskliniken, Johannes Wesling Klinikum Minden
Minden, Germany
Actively Recruiting
44
LMU Klinikum München-Großhadern
München, Germany
Actively Recruiting
45
Rotkreuzklinikum München
München, Germany
Actively Recruiting
46
Universitätsklinikum Münster
Münster, Germany
Actively Recruiting
47
Klinikum Neumarkt
Neumarkt, Germany
Actively Recruiting
48
MVZ Nordhausen
Nordhausen, Germany
Actively Recruiting
49
Ortenau Klinikum Offenburg-Kehl
Offenburg, Germany
Actively Recruiting
50
St. Vincenz Krankenhaus GmbH
Paderborn, Germany
Actively Recruiting
51
Studienzentrum Onkologie Ravensburg
Ravensburg, Germany
Actively Recruiting
52
Krankenhaus Barmherzige Brüder
Regensburg, Germany
Actively Recruiting
53
Klinikum am Steinenberg
Reutlingen, Germany
Actively Recruiting
54
RoMed Klinikum Rosenheim
Rosenheim, Germany
Actively Recruiting
55
Klinikum Südstadt Rostock
Rostock, Germany
Actively Recruiting
56
Thüringen-Kliniken "Georgius Agricola"
Saalfeld, Germany
Actively Recruiting
57
Leopoldina Krankenhaus Schweinfurt
Schweinfurt, Germany
Actively Recruiting
58
g.SUND
Stralsund, Germany
Actively Recruiting
59
Klinikum Stuttgart
Stuttgart, Germany
Actively Recruiting
60
Klinikum Traunstein
Traunstein, Germany
Actively Recruiting
61
Klinikum Mutterhaus
Trier, Germany
Actively Recruiting
62
Universitätsklinikum Tübingen
Tübingen, Germany
Actively Recruiting
63
Universitätsklinik Ulm
Ulm, Germany
Actively Recruiting
64
St. Josefs-Hospital
Wiesbaden, Germany
Actively Recruiting
65
Klinikum Worms
Worms, Germany
Actively Recruiting
Research Team
S
Sandra Polleis
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here